Vinorelbine in Treating Older Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Phase 2

Completed

• Conditions: Lung Cancer
• Interventions: Drug: vinorelbine tartrate

• Registration Number: NCT00008333
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of vinorelbine taken by mouth in treating older patients who have stage IIIB or stage IV non-small cell lung cancer.

Detailed Description

OBJECTIVES: I. Determine the objective response rate in elderly patients with stage IIIB or IV non-small cell lung cancer treated with oral vinorelbine. II. Determine the time to progression in patients treated with this drug. III. Determine the toxicity of this drug in these patients. IV. Determine whether there is a perceived preference for this oral administration in these patients. V. Determine the quality of life of these patients when treated with this drug. VI. Assess individual variation in responses, pharmacokinetic parameters, and/or biological correlates in patients treated with this drug.

OUTLINE: Patients receive oral vinorelbine on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and after 8 weeks of therapy. Patients are followed every 3 months for 5 years.

Study Timeline

• Study First Submitted: 2001-01-06
• Study Start: 2001-04
• Study First Submitted QC: 2004-02-02
• Study First Posted: 2004-02-03
• Primary Completion: 2004-03
• Study Completion: 2007-07
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vinorelbine	vinorelbine tartrate	Patients receive oral vinorelbine on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and after 8 weeks of therapy. Patients are followed every 3 months for 5 years.

Primary Outcome Measures

Name	Time	Method
objective response rate	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
Time to progression	Up to 5 years
Quality of life	Up to 5 years

Trial Locations

Locations (13)

Siouxland Hematology-Oncology; 🇺🇸 Sioux City, Iowa, United States

CCOP - Geisinger Clinic and Medical Center; 🇺🇸 Danville, Pennsylvania, United States

CCOP - Cedar Rapids Oncology Project; 🇺🇸 Cedar Rapids, Iowa, United States

CCOP - Wichita; 🇺🇸 Wichita, Kansas, United States

CCOP - Scottsdale Oncology Program; 🇺🇸 Scottsdale, Arizona, United States

CCOP - Carle Cancer Center; 🇺🇸 Urbana, Illinois, United States

CCOP - Sioux Community Cancer Consortium; 🇺🇸 Sioux Falls, South Dakota, United States

CCOP - Merit Care Hospital; 🇺🇸 Fargo, North Dakota, United States

CCOP - Metro-Minnesota; 🇺🇸 Saint Louis Park, Minnesota, United States

Rapid City Regional Hospital; 🇺🇸 Rapid City, South Dakota, United States

Mayo Clinic Cancer Center; 🇺🇸 Rochester, Minnesota, United States

CCOP - Missouri Valley Cancer Consortium; 🇺🇸 Omaha, Nebraska, United States

CCOP - Toledo Community Hospital Oncology Program; 🇺🇸 Toledo, Ohio, United States